The Drugs Information Association (DIA) India is organizing a 2-day seminar titled 'New Insights into Current Pharmacovigilance Challenges' from March 8  to 9, 2013 at the Vivanta by Taj - Yeshwantpur, Bengaluru.

The key objective is to provide an update on the recently released GPvP Modules by EMA and an insight into the Japanese Model of EPPV which is seen to be a way forward for other Asian countries.

It would also highlight PV inspection readiness, global outsourcing trends in PV-Indian potential and challenges by China, Taiwan, and Latin America; role of pharmacogenomics in drug safety; modernizing Pharmacovigilance processes through analytics and cloud; and technology watch against safety hazard of spurious-adulterated drugs.

The conference will also bring to the fore challenges in causality analysis and address issues  in authoring periodic safety update report (PSUR) for generic manufacturers. It will  focus on  Drug Induced Liver Injury (DILI), management of vaccine safety and deal with efficient management of literature search.

There is also a panel discussion on ‘Compensation for Trial Related Injuries’ by Milind Sardesai, Project Lead and Domain Consultant - Life Sciences, Tata Consultancy Services, Mubarak Naqvi, director, Clinical Research (India), Sanofi and  Krishna Sarma, managing partner, Corporate Law Group.

At the conclusion of this conference, participants will be able to comprehend aspects of current global safety reporting requirements for prescription and over-the-counter drugs. They will be able to discuss new pragmatic approaches to pharmacovigilance as proposed by the Council for International Organizations of Medical Sciences (CIOMS) working group, understand  the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan,  besides identify best practices for quality assurance in post marketing pharmacovigilance and clinical safety

All attendees will receive a DIA Certificate of attendance at the conclusion of the event.

DIA has stated that the event would be important for professionals with experience in clinical safety and who are involved in pharmacovigilance, clinical research, risk management, compliance, medical information, regulatory affairs,  academia and pharmacology.

 The two day programme is co-chaired by Moin Don, Executive Director and Founder, PVCON Pharmacovigilance Consulting Services and  Vivek Ahuja, Director, Pharmacovigilance Asia-Pacific, Baxter Healthcare.

Keynote speakers are Dr Surinder Singh, Director in Charge, National Institute of Biologicals, Dr. Stewart Geary, chief medical officer, vice president and general manager of corporate medical affairs, Headquarters Eisai Co., Ltd.,  Pradip Paul, PV and Risk Management Consultant, Boehringer Ingelheim, US and  Dr Y K Gupta, Prof and Head, Dept. of Pharmacology, All India Institute of Medical Sciences, New Delhi.

Angela Pitwood, VP Pharmacovigilance, IPM Safety Services, Inc.(a division of IndiPharm, US) is the distinguished speaker for the session.

Sessions would cover Regional PV Update,  Impact of New EU Regulations– Scope of Change, Pharmacovigilance Process and Science, Haemovigilance and Biovigilance which would also cover the Indian programmes, Future of Drug Safety, Practical Aspects in Pharmacovigilance, PV Emerging Challenges, Pharmacovigilance Trends among others.